Suturing construct with spliced tails

ABSTRACT

A surgical construct having a flexible strand with a middle region and at least two opposing tail regions that are spliced to form a single tail. The middle region has a first diameter and the opposing tail regions have a second diameter, which is smaller than the first diameter. The tail regions may have similar or different diameters. Because of the thin spliced tail regions, the suturing construct of the present invention can be easily inserted into suture/tape passing and retrieving instruments and passed through soft tissue (such as a rotator cuff). Once the suturing construct has been passed through tissue, the splice may be cut to allow the suture/tape to have again individual tails.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional of application Ser. No. 12/646,786, filed Dec. 23,2009, now U.S. Pat. No. 8,843,521, which claims the benefit of U.S.Provisional Application No. 61/140,552, filed Dec. 23, 2008, the entiredisclosures of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to surgical sutures and, moreparticularly, to a suture with spliced tails.

BACKGROUND OF THE INVENTION

The SutureBridge™ tendon repair technique, developed by Arthrex, Inc.,and disclosed in U.S. Patent Publication No. 2007/0191849, thedisclosure of which is herein incorporated by reference, consists of atied medial row constructed with two threaded suture anchors, combinedwith knotless lateral fixation using two Arthrex PushLock® anchors. Theconstruct, shown in FIG. 1A, enhances footprint compression and promotestendon healing-to-bone with minimal knot tying.

The SpeedBridge™ technique, also developed by Arthrex, Inc., uses athreaded swivel anchor (such as disclosed in U.S. Patent Publication No.2008/0004659, the disclosure of which is herein incorporated byreference) combined with FiberTape® (disclosed in U.S. PatentPublication No. 2005/0192631), the disclosure of which is hereinincorporated by reference) to create a quick and secure SutureBridgeconstruct with no knots and only two suture passing steps.

In the SpeedBridge™ technique, a swivel anchor, preferably an Arthrex4.75 mm SwiveLock® C, loaded with one strand of FiberTape®, is insertedinto a medial bone socket. A suture shuttle such as FiberLink™ is usedto shuttle both FiberTape® tails through the rotator cuffsimultaneously. A FiberLink™ tail is passed through the rotator cuffusing a suture passing instrument such as the Scorpion™. The tails ofthe FiberTape® are loaded through the FiberLink™ loop and shuttledthrough the rotator cuff. These steps are repeated for the second medialrow anchor.

FIG. 1B depicts the SwiveLock® C loaded with one strand of FiberTape®being inserted into the bone socket.

Next, as shown in FIG. 1C, one FiberTape® tail from each medial anchoris retrieved and loaded through the SwiveLock® C eyelet. The loadedeyelet is inserted into a prepared lateral bone socket until the anchorbody contacts bone, and the tension is adjusted if necessary.

The SwiveLock® C driver is rotated in a clockwise direction to completethe insertion. Using a cutter, the FiberTape® tails are cut, one and atime, to complete the technique. A completed suture in accordance withthe SpeedBridge™ technique is shown in FIG. 1D.

In the above-described SpeedBridge™ technique, it can be difficult toshuttle (pass) the two FiberTape® tails through the rotator cuffsimultaneously. Accordingly, it would be desirable to provide a lengthof FiberTape® with a splice leading to a single tail that can be easilyloaded into the tissue passing instrument, and then cut to again havetwo FiberTape® tails for completing the SpeedBridge™ construct.

SUMMARY OF THE INVENTION

The present invention fulfills the needs noted above by providing asurgical construct comprising a flexible strand with both opposing endsterminating in a same single tail. The invention provides a suture ortape construct having a middle region and at least two opposing tailregions that are spliced to form a single tail. The middle regionpreferably has a first diameter and the opposing tail regions have asecond diameter which is smaller than the first diameter. The tailregions may have similar or different diameters from each other.

Because of the thin spliced tail region, the suture construct of thepresent invention can be more easily inserted into suture/tape passingand retrieving instruments and passed through tissue than regularsuture/tape. After the suture or tape is passed through tissue, thesplice can be cut to have again two tails of suture or tape.

The invention also provides a system for surgical repairs comprising: afixation device comprising an anchor body or a screw and an eyelet; anda suture construct comprising a flexible strand with both opposing endsterminating in a same single tail, wherein the flexible strand isconfigured in the form of a flexible loop with a splice leading to thetail, and wherein the flexible loop comprises a first region of a firstdiameter and two regions of a second diameter, the first diameter beinggreater than the second diameter, the suture construct being pre-loadedon the fixation device, the flexible loop being threaded through theeyelet of the fixation device.

These and other features and advantages of the present invention willbecome apparent from the following description of the invention that isprovided in connection with the accompanying drawings and illustratedembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWING

FIGS. 1A-1D illustrate tendon repair techniques.

FIG. 2 illustrates a suturing construct with spliced tails according toan exemplary embodiment of the present invention; and

FIGS. 3-12 illustrate subsequent steps of a method of soft tissue repair(arthroscopic rotator cuff repair) with the suturing construct of FIG.2, and according to an exemplary embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a surgical construct having a middleregion and at least two opposing tail regions that are spliced to form asingle tail. The middle region has a first diameter and the opposingtail regions have a second diameter, which is smaller than the firstdiameter. The tail regions may have similar or different diameters.Because of the thin spliced tail regions, the suturing construct of thepresent invention can be easily inserted into suture/tape passing andretrieving instruments (such as the Arthrex Scorpion™) and passedthrough soft tissue (such as a rotator cuff). Once the suturingconstruct has been passed through tissue, the splice may be cut to allowthe suture/tape to have again individual tails.

Referring now to the drawings, where like elements are designated bylike reference numerals, FIG. 2 illustrates an exemplary embodiment of alength of surgical construct 10 with spliced tails according to thepresent invention. Although the invention will be described below withreference to a suture tape construct with two tails, the invention alsocontemplates embodiments wherein the construct is a large diametersuture, or a combination of suture and tape, or wherein the constructincludes multiple strands of suture or suture tape with any number oftails (at least two of the tails being spliced).

According to an exemplary embodiment only, the suturing construct 10 isformed of a flexible strand with a middle region 2 (suture section 2)which is adjacent two tail regions 4 and 6 and a splice (or single tail)11. As shown in FIG. 2, the diameter of the tail region 4 may be similarto or different than the diameter of the tail region 6. In any event,each of the diameters of the tail regions 4, 6 is smaller than thediameter of the middle region 2.

In an exemplary embodiment, the middle region 2 (suture section 2) ofthe suturing construct 10 has a gradual taper in diameter (for example,from a #2 to #0 from section 2 to sections 4, 6 and single tail 11) madeon a braiding machine. The single tail 11 of the construct 10 may beformed by splicing together the tail regions 4, 6 through splice 11 a.The splice 11 a may be done in a manner that provides a smoothtransition. In another embodiment, the splice 11 a and the single tail11 may be formed by joining together at least a portion of each of tailregions 4, 6 to form flexible loop 9 and single tail 11. The joining ofat least a portion of each of tail regions 4, 6 may be accomplished bybraiding the tail regions, or by gluing them, or by other known methodin the art. As a result of the smaller diameter of the tail regions 4,6, and of the single tail 11, the suturing construct 10 of the presentinvention is more easily threaded through a suture passing instrument,and passed through tissue.

Middle section 2 may have cross-sections of various forms andgeometries, including round, oval, rectangular, or flat, among others,or combination of such forms and geometries. In an exemplary embodimentonly, section 2 may be provided as a suture tape or as a round suture,or as a combination of tape and round suture. The diameter of middlesection 2 may be constant or may vary. Preferably, the diameter ofsection 2 is constant and is greater than the diameter of sections 4, 6and of the spliced single tail 11.

FIG. 2 illustrates suturing construct 10 threaded through a knotlessfixation device 62 such as an Arthrex PushLock® C anchor (as disclosedand described in U.S. Patent Application Publication No. 2004/0093031,the disclosure of which is incorporated by reference in its entirety) oran Arthrex SwiveLock® C anchor (as shown in FIG. 2, and as disclosed anddescribed in U.S. Patent Application Publication No. 2007/0191849, thedisclosure of which is incorporated by reference in its entirety). Thefixation device 62 comprises an anchor body (or screw) 63 and an eyelet64.

As shown in FIG. 2, construct 10 is pre-loaded (manufactured) on thefixation device 62 (i.e., the suture construct 10 is pre-loaded througheyelet 64 of the knotless fixation device 62 (SwiveLock® anchor 62)). Asdescribed in more detail below, the fixation device 62 with thepre-loaded suture construct 10 is first inserted into a bone socket ortunnel. Subsequent to the insertion into the bone socket, the tail 11 ispassed through the tissue to be repaired. After passing the sutureconstruct 10 through the tissue (with the advantage of a single tail11), the splice is cut to open the loop of the construct and to formagain two ends of the suture or suture tape. Each of the two ends may beemployed further for tissue fixation, for example, the two ends may beindividually threaded through additional eyelets of additional fixationdevices and may be inserted in additional pilot holes (with additionalfixation devices) to complete the suture repair system.

The spliced suture construct 10 of the present invention may be employedfor various soft tissue to bone repairs that employ at least oneknotless fixation device. According to an exemplary embodiment only, thesurgical construct 10 of the present invention may be employed in amethod for double row fixation of tendon to bone, as detailed in U.S.Patent Application Publication No. 2007/0191849. A method of exemplarytissue fixation with the surgical construct 10 of the present inventioncomprises inter alia the steps of: (i) providing surgical construct 10pre-loaded (manufactured) on a fixation device (for example, a knotlessfixation device); (ii) securing the fixation device with the pre-loadedconstruct 10 into a bone socket or tunnel; (iii) passing the suturingconstruct 10 through tissue to be repaired; (iv) removing the splice ofthe suturing construct 10 to release the two tail regions of theconstruct; and (v) employing at least one of the two released tailregions to fixate tissue.

Reference is now made to FIGS. 3-12 which illustrate subsequent steps ofa method of soft tissue repair (arthroscopic rotator cuff repair) withthe suturing construct 10 of FIG. 2, and according to an exemplaryembodiment of the present invention. FIG. 3 illustrates a side view of ahuman shoulder of a patient undergoing a repair of rotator cuff 80 inaccordance with an exemplary embodiment of the present invention.Although this particular embodiment will be illustrated below withreference to FIGS. 3-12 and with reference to only a particular knotlessfixation device (such as Arthrex SwiveLock® C anchor), the invention isnot limited to this particular embodiment and contemplates additionalembodiments wherein any knotless fixation device may be employed,depending on the characteristics of the repair site and of theparticular application.

The mobility of the tear is assessed using, for example, a tissuegrasper 82 (FIG. 3) such as the Arthrex KingFisher™ SutureRetriever/Tissue Grasper, to determine whether a U or L-shaped componentexists.

FIG. 4 illustrates the preparation of two pilot holes 60 for two sutureanchors that will be inserted in the medial row. A punch may be employedadjacent to the articular margin of the humerus and at about 45 degreeangle to form the two pilot holes. Subsequent to the formation of thepilot holes 60, and as shown in FIGS. 5-7, two fixation devices 62 witha pre-loaded suturing construct 10 are placed in the pre-formed holes 60in the medial row. These fixation devices assure full contact of thedetached tendon 80 along the medial footprint of the greater tuberosity.

As illustrated in FIG. 5, suturing construct 10 is pre-loaded(manufactured) on the fixation device 62, i.e., the suture construct 10is pre-loaded through eyelet 64 of the knotless fixation device 62(SwiveLock® anchor 62) on the distal end 66 of the driver 68.

Subsequently, and as shown in FIG. 5, the distal tip 66 of the knotlessfixation device 62 (with the pre-loaded construct 10) is brought to theedge of the pilot hole 60. The driver 68 is then completely advancedinto the pilot hole 60 until the anchor body or screw 63 contacts thebone. The driver is rotated in a clockwise direction, for example, tocomplete insertion. A mallet may be employed to impact the anchor body63 into the pilot hole 60 until the anchor body is flush with thehumerus. The driver 68 is then turned counterclockwise to disengage theeyelet 64 (within pilot hole 60) from the driver shaft. The stepsdescribed above are subsequently repeated for the second knotlessfixation device 62 (for example, a second SwiveLock anchor) with anotherpre-loaded construct 10.

Subsequent to the securing of the knotless fixation devices 62 (withsuturing construct 10 pre-loaded through eyelets 64 of the knotlessfixation devices 62) within the bone sockets or tunnels, the tail 11 ofthe construct 10 is passed through the tissue to be repaired, i.e.,through rotator cuff 80. For example, and as shown in FIG. 6, a sutureshuttle (such as FiberLink™) and a suture passing instrument 44 (such asthe Scorpion™) are used to shuttle tail 11 through the rotator cuff 80.The tail 11 of the construct 10 is loaded through the FiberLink™ loopand shuttled through the rotator cuff 80. Because of the thin splicedtail region 11, the suturing construct 10 of the present invention canbe easily inserted into passing and retrieving instruments (such as theArthrex FiberLink™ and/or Scorpion™) and passed easily through softtissue (such as the rotator cuff 80).

Reference is now made to FIG. 7. Once the suturing construct 10 has beenpassed through tissue 80, the splice 11 a is cut to allow thesuture/tape to have again individual tails 22. FIG. 7 illustrates thetwo knotless fixation devices 62 with the two suturing constructs 10having splices 11 a removed (i.e., splice 11 a is cut to open the loop 9of the construct and to form again two tails 22 of each of theconstructs).

Each of the two ends 22 of the suture or suture tape may be employedfurther for tissue fixation, for example, each of the two ends may bethreaded through additional eyelets of additional fixation devices andmay be inserted in additional pilot holes (with additional fixationdevices) to complete various suture repairs of the present invention. Inan exemplary embodiment only, one tail 22 from each of the anchors 62 isretrieved and then loaded through another fixation device (for example,through another fixation device 62) and inserted within pilot holes 70(FIGS. 9-11) of a lateral row of the suture repair 100 (FIG. 12). Tails22 are inserted into prepared lateral bone sockets 70 until the anchorbody contacts the bone. Tension is adjusted if necessary. The SwiveLock®driver is rotated in a clockwise direction to complete insertion. Thetails 22 are cut, preferably one at a time, with an exemplary open-endedinstrument (FiberWire® cutter) to complete formation of criss-crosssuturing pattern 100 (FIG. 12) of the present invention.

The suturing construct 10 of the present invention described above maybe formed of strands of a high strength suture material withsurgically-useful qualities, including knot tie down characteristics andhandling, such as Arthrex FiberWire® suture disclosed in U.S. Pat. No.6,716,234, the disclosure of which is incorporated herein by reference.The suture construct may be formed of optional colored strands(preferably black) to assist surgeons in distinguishing between suturelengths with the trace and suture lengths without the trace. Preferably,each of tail regions 4, 6 may be provided in different colors to assistsurgeons in retrieving one tail from each of the knotless fixationdevices and then loading them through another fixation device, duringthe formation of the criss-cross suturing pattern 100 (FIG. 12).

Suturing construct 10 may be preferably coated (partially or totally)with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone(Dow Corning silicone fluid 202A or others), silicone rubbers (Nusil Med2245, Nusil Med 2174 with a bonding catalyst, or others) PTFE (Teflon,Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose(Filodel) or other coatings, to improve lubricity of the suture or tape,knot security, pliability, handleability or abrasion resistance, forexample.

In additional embodiments, middle region 2 may be formed of polyester(for example, braided polyester) and the suture tail 11 may be alsoformed of polyester or a similar material. In an exemplary embodimentonly, middle region 2 may be formed of braided polyester with apolyester core, and suture tail 11 may be braided polyester with apolyester core and spliced to the suture. The middle region and tail maybe coated as detailed above. In addition, a coating may be provided tothe yarns forming the suture construct 10 before braiding. Polyesteryarns for the braided construct of the middle region 2 may be coatedusing a silicone elastomer (or a similar material as detailed above)prior to braiding. Similarly, the suture tails 4, 6 may be coated usingthe same or different coating material after braiding and beforesplicing. If desired, at least one of the tail regions 4, 6, 11 ofsuture construct 10 (preferably both tail regions 4, 6 and spliced tail11) may be coated, impregnated, or otherwise stiffened with a materialsuch as plastic, for example. Preferably, end tail 11 may have a veryfine end that is coated, impregnated, or stiffened with a material suchas plastic, for example.

Suture construct 10 may also contain a bioabsorbable material, such asPLLA or one of the other polylactides, for example, and/or may be formedof twisted fibers having strands of a contrasting color added to thebraided threads, to make the suture more visible during surgicalprocedures. The colored strands, preferably, may be dyed filaments orstrands.

The tail regions 4, 6 and the single tail 11 of the suture construct 10may be also provided with tinted tracing strands, or otherwise contrastvisually with the middle region of the suture construct, which remains aplain, solid color, or displays a different tracing pattern, forexample. Accordingly, when the suture construct is loaded through theeyelet of a suture anchor or passed through tissue, for example, atleast one of the tail regions 4, 6 of the suture construct, or thesingle tail 11, or the middle region 2, may be visually coded, makingidentification and handling of the suture legs simpler. Easyidentification of suture in situ is advantageous in surgical procedures,particularly during arthroscopic surgeries, such as endoscopy andlaparoscopy.

The suture construct 10 of the present invention has applicability tosuture applications that may be employed in surgical procedures such asrotator cuff repair, Achilles tendon repair, patellar tendon repair,ACL/PCL reconstruction, hip and shoulder reconstruction procedures, andapplications for suture used in or with suture anchors. In exemplaryembodiments only, and as detailed above, the suture construct of thepresent invention may be employed in suture applications that do notinvolve knot tying, for example, for use with suture anchors (such asPushLock® suture anchor) or for knotless arthroscopic suture repairs(such as knotless single row rotator cuff repair, or SpeedBridge™ repairusing no knots and only suture passing steps as described above), amongmany others.

While the present invention is described herein with reference toillustrative embodiments for particular applications, it should beunderstood that the invention is not limited thereto. Those havingordinary skill in the art and access to the teachings provided hereinwill recognize additional modifications, applications, embodiments andsubstitution of equivalents all fall within the scope of the invention.Accordingly, the invention is not to be considered as limited by theforegoing description.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A surgical construct comprising a flexiblestrand with both opposing ends terminating in a same single tail.
 2. Thesurgical construct of claim 1, wherein the flexible strand is a suturestrand or a suture tape, or a combination of suture stand and suturetape.
 3. The surgical construct of claim 1, wherein both opposing endsare spliced to form a splice connecting the flexible strand to thesingle tail.
 4. The surgical construct of claim 1, wherein the singletail is coated with a material comprising wax, silicone,polytetrafluoroethylene, and polybutylate acid.
 5. The surgicalconstruct of claim 1, wherein the flexible strand forms a flexible loopwhen the ends terminate in the same single tail, the flexible loopcomprising at least two different regions with different diameters. 6.The surgical construct of claim 1, wherein the single tail is coatedwith a plastic material.
 7. The surgical construct of claim 1, whereinthe single tail is impregnated with a plastic material.
 8. A suturingconstruct, comprising: a flexible loop; and a splice connecting theflexible loop to a flexible strand.
 9. The suturing construct of claim8, wherein the flexible loop comprises a first region of a firstdiameter and two regions of a second diameter, the first diameter beinggreater than the second diameter.
 10. The suturing construct of claim 9,wherein the two regions of the second diameter have fiber strands ofcontrasting colors.
 11. The suturing construct of claim 9, wherein theflexible loop, the first and second regions, and the flexible strand allhave fiber strands of contrasting colors.
 12. The suturing construct ofclaim 9, wherein the flexible strand has a third diameter about equal tothe second diameter.
 13. The suturing construct of claim 8, wherein theflexible loop is a continuous suture loop or a continuous suture tapeloop.
 14. The suturing construct of claim 8, wherein the flexible loopis surrounded by a cover.
 15. The suturing construct of claim 8, whereinthe cover comprises braided suture of a high strength material.
 16. Thesuturing construct of claim 8, wherein the flexible loop is tapered in adirection towards the flexible strand.
 17. The suturing construct ofclaim 8, wherein at least one of flexible loop and the flexible strandcontains a bioabsorbable material.
 18. A suturing construct, comprising:a first region; and a first and a second end regions located at oppositeends of the first regions, wherein at least a portion of the first endregion is joined to at least a portion of the second end region to forma joined region.
 19. The suturing construct of claim 18, wherein thejoined region is a splice with a single tail.
 20. The suturing constructof claim 18, wherein the joined region is formed by splicing together atleast a region of the first end region and at least a region of thesecond end region.
 21. The suturing construct of claim 18, wherein thefirst region, and the first and second end regions all have fiberstrands of contrasting colors.
 22. The suturing construct of claim 18,wherein the first region is a braided suture.
 23. A system for surgicalrepairs, comprising: a fixation device comprising an anchor body and aneyelet; and a suture construct pre-loaded on the fixation device, thesuture construct comprising a continuous flexible loop and a single tailattached to the loop, the flexible loop being threaded through theeyelet of the fixation device.
 24. The system of claim 23, wherein thecontinuous flexible loop further comprises a first region of a firstdiameter, a second region of a second diameter, and two transitionalregions of a third diameter, the two transitional regions connecting thefirst region to the second region, wherein the third diameter tapersbetween the first diameter and the second diameter, and wherein thesingle tail is attached to the second region.
 25. The system of claim23, wherein the suture construct is a suture or a suture tape.